The Treatment of Insomnia in Patients With HIV Disease
|HIV Infections Insomnia||Drug: Doxepin Drug: Temazepam Drug: Placebo||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Randomized, Double-blind, Placebo Controlled Study to Assess the Efficacy and Safety of Doxepin and Temazepam in HIV Seropositive Patients With Insomnia.|
- Response: Change in Insomnia Severity Rating Scale at 3 Months. [ Time Frame: Baseline and 3 months ]Insomnia Severity Index; It is a measure of Insomnia Severity; A higher number indicates greater severity of insomnia. Range of possible score totals is 0-28.
- Change in Piper Fatigue Scale at 3 Months [ Time Frame: Baseline and 3 months ]A 22 item scale measuring level of fatigue, with possible totals ranging from 22-220. A higher number indicates greater severity of fatigue.
|Study Start Date:||March 2007|
|Study Completion Date:||August 2010|
|Primary Completion Date:||August 2010 (Final data collection date for primary outcome measure)|
Placebo Comparator: Placebo
Placebo capsule nightly for duration of study
Active Comparator: 2
Doxepin 10 mg po nightly x duration of study length OR Temazepam 15 mg po nightly x duration of study length OR Placebo nightly x duration of study length
Active Comparator: 3
Temazepam capsule 15 mg po nightly x duration of study
Insomnia is a disorder defined as persistent difficulty falling asleep, staying asleep or non-restorative sleep which is associated with diminished daytime function without any identifiable underlying cause. This condition is extremely common among HIV infected individuals and can lead to significant distress and reduction in the quality of life. The mechanisms for disrupted sleep in this population are diverse, including potential direct effects of the tat protein upon the sleep centers in the central nervous system. Insomnia has been documented to be one of the most common psychiatric disorders in HIV disease, but no trial has systematically examined the efficacy of available hypnotic agents, which are commonly used in this population.
Comparison(s): Two commonly prescribed hypnotic agents used for insomnia will be compared to placebo over a 6 month treatment study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00465972
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||Andrew D Krystal, MD||Duke University|